QC Methods Associate

at  BERKSHIRE STERILE MANUFACTURING LLC

POSITION SUMMARY

The QC Methods Associate is responsible for activities associated with the transferring and establishment of new test methods at BSM. They also support other activities associated with QC testing for starting materials, finished product, and stability. This position provides technical knowledge in analytical instrumentation and chemistry laboratory experiment design.

EXPERIENCE

• No QC GMP experience required. Experience in QC laboratory or related experience in a chemistry laboratory preferred.
• Experience with HPLC and/or UPLCs and UV/Vis spectrophotometers preferred.
• Experience related to Quality Systems with exposure to GMP environment is not required but, is preferred.

EDUCATION

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or related science

KNOWLEDGE, SKILLS & ABILITIES

• Proficient in Microsoft Office Suite applications.
• Experience with wet chemistry and analytical chemistry.
• Able to effectively communicate verbally and in writing
• “Do-what-it-takes” attitude.
• Excellent organizational skills.
• Able to multi-task in an extremely fast-paced environment with changing priorities.
• Satisfactory audio-visual acuity and the ability to read and write English

PHYSICAL REQUIREMENTS

• Ability to sit for prolonged periods of time,
• Ability to stand for prolonged periods of time
• Able lift up to 40lbs

DUTIES AND RESPONSIBILITIES

• Work as part of a cross-functional team to perform QC activities for technology transfer of manufacturing and testing processes to BSM from external CMO/CTOs.
• Interact with customers to ensure appropriate tests and specifications are in place for their products.
• Write and review QC SOPs, test methods, finished product specifications and qualification/validation protocols and reports, as needed.
• Participate in projects for specific methods
• Draft and review analytical modules of batch records.
• Perform analyses to support general QC testing as needed: testing of starting materials, finished product, and stability samples.
• Performing methods with the following but, are not limited to: HPLC/UPLC, spectrophotometry, pH, osmolality, USP particulate matter.
• Perform assay troubleshooting and identifying and implementing improvements to existing assays.
• Participate in deviation investigations, change controls, CAPAs, OOT/OOS.
• Ensure testing is in compliance with all applicable Regulatory requirements.
• Ensure Standard Operating Procedures are in place for all testing procedures and supporting procedures.
• Identify and implement process/procedural improvements related to Quality Control functions to improve efficiencies and effectiveness.
• Maintain control and confidentiality of documents and information.
• Other duties as assigned.

REGULATORY RESPONSIBILITIES

• To meet Regulatory requirements and standards set internally by BSM.
• Conduct business in a responsible manner that complies with all state, FDA, and OSHA regulations, or otherwise as applicable. Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines.